Endoscopic Full Thickness Resection With Laparoscopic Assistance

Gastric Subepithelial Tumor Clinical Trial

— EFTR-LA  

Official title:

Endoscopic Full Thickness Resection With Laparoscopic Assistance, Single Center Single Arm Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02042079
• Other study ID #: NCCCTS-604
• Status: Recruiting
• Phase: Phase 1
• First received: January 19, 2014
• Last updated: January 19, 2014
• Start date: July 2012

Study information

• Verified date: January 2014
• Source: National Cancer Center, Korea
• Contact: Chan G Kim, M.D.
• Phone: +82-31-920-1620
• Email: glse[@]chol.com
• Is FDA regulated: No
• Health authority: Republic of Korea: Ministry of food and durg safety
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the feasibility of endoscopic full-thickness resection with laparoscopic assistance.

Description:

The laparoscopic resection with a linear stapler for subepithelial tumors (SET) can lead to excessive resection of healthy tissue of the gastric wall resulting in deformity or stenosis. Attaining a positive surgical margin is also possible. Endoscopic full-thickness resection (EFTR) can be used for tumor resection by direct visualization of the tumor from inside the stomach lumen leading to a free surgical margin with little resection of healthy tissue. In order to overcome current endoscopic technical limitations, we will combine the conventional laparoscopic approach with EFTR.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Gastric subepithelial tumor

• Invasion of muscularis propria on Endoscopic ultrasound

• Tumor size 1.5cm-5cm or increasing size during follow-up

Exclusion Criteria:

• Bleeding tendency,

• Inappropriate condition for surgery with general anesthesia

• Refuse to be enrolled to study

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Subepithelial Tumor

Intervention

Procedure:
• EFTR with LA
(Endoscopic full-thickness resection with laparoscopic assistance)

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center	Goyang	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	En-bloc resection and successful closure	successful En-bloc resection of subepithelial tumor and successful closure of resection site by Endoscopic full-thickness resection with laparoscopic assistance.	3 months after surgery	No
Secondary	number of troche		during surgery	No